TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VIRTUOSAPH PLUS, WITH RADIAL; LAPAROSCOPE, GENERAL
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Model Number VSP550EX |
Device Problems
Melted (1385); Failure to Cut (2587); Sparking (2595)
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Patient Problems
Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).
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Event Description
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The user facility reported to terumo cardiovascular that during vein harvesting, the cutter had sparks, melted and could not cut.As per subsidiary, when the surgeon used the harvester to cut branches that the cutter had sparks happened.After about 12 times cutting, the cutter was melted and could not cut.As per the clinical specialist, looking at the picture provided it would suggest too much pressure was put on the cutting tip while in use.Further, the stated generator wattage was said to be set at 15.This is certainly higher than the suggested settings and may be contributory.Additionally the generator settings used was bipolar, macro in 15 watts.There was a delay of around 15-20 minutes.The product was changed out.Procedure was completed successfully.
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Manufacturer Narrative
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This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on december 14, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 3039, 4614, 4582, 11, 3331, 4114, 3221, 4315).Component code: 3039 - cautery tip.Health effect - impact code: 4614 - serious injury/ illness/ impairment.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 4114 - device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The affected sample was not returned for evaluation; however, photos provided were reviewed and confirmed the issue a representative retention sample was reviewed with no anomalies.The v-cutter on the retention sample was fully intact.During the manufacturing process, all vsp550 are visually inspected and tested for functionality and performance along with inspection for v-cutter mechanism, prior to packaging.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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Search Alerts/Recalls
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